IRB Procedures and Guidelines

The University of Detroit Mercy Institutional Review Board

The membership of the Institutional Review Board is appointed by the vice president for Academic Affairs in consultation with the deans of the colleges and schools. The IRB is comprised of members from diverse backgrounds to promote complete and adequate review of research activities, and has the professional competence necessary to review the specific research activities which are assigned to it. The board is sufficiently qualified through the experience and expertise of its members, and the diversity of the members' backgrounds including consideration of the racial and cultural backgrounds of members and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of volunteers.

When research is reviewed involving a category of vulnerable volunteers (e.g., prisoners, children, individuals institutionalized as mentally disabled), the IRB shall include in its reviewing body one or more individuals who have as a primary concern the welfare of these volunteers. The board includes both male and female members as well as individuals representing a variety of professions. The Detroit Mercy IRB also includes several members who are not otherwise affiliated with the institution and who are not a part of the immediate family of persons who are affiliated with the institution.

The IRB Review

The purpose of the review is to protect the rights and welfare of volunteers in research projects as required by federal regulations. The IRB has the authority to approve, require modifications in (to secure approval), or disapprove research based on its review. In conducting the review the IRB assures that:

A. Risks to volunteers are minimized by using procedures consistent with sound research design and which do not unnecessarily expose volunteers to risk, and whenever appropriate, by using procedures already being performed on the volunteers for diagnostic or treatment purposes.

B. Risks to volunteers are reasonable in relation to anticipated benefits, if any, to volunteers, and the importance of the knowledge that may be expected to result.

C. Selection of volunteers is equitable.

D. Informed consent will be sought from each prospective volunteer or the volunteer's legally authorized representatives and will be documented in accordance with, and to the extent required, by FDA's informed consent regulations.

E. Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of volunteers.

F. There are adequate provisions to protect the privacy of volunteers and to maintain the confidentiality of data.

G. Appropriate additional safeguards have been included in the study to protect the rights and welfare of volunteers who are members of a particularly vulnerable group.

To make these determinations, the IRB weighs the following:

Knowledge to be gained from the study

Prior experimental and clinical findings

Potential benefits to the volunteer

Potential risks and procedures to minimize these risks

Confidentiality procedures

Informed consent process

Only when the IRB has decided that the answers to the above are adequate for the protection of the volunteer, does it approve the project.

IRB Oversight and Reporting

IRB approval of the project does not end its oversight of the project. Prior to initiating any changes to the project, investigators are required to report any planned project or consent form changes to the IRB for approval. Investigators also must report any unforeseen complications that occur to the IRB within 48 hours of the occurrence. The IRB may, as a result of the complications, withdraw its approval of the project or require the investigator to add additional safeguards for the volunteer to the study before it can be resumed. The IRB conducts continuing reviews of research at intervals appropriate to the degree of risk, but not less than once per year. The IRB also has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's decisions, conditions and requirements or that has been associated with unexpected serious harm to volunteers.

Additionally, the IRB has the authority and is responsible for promptly reporting information to Academic Affairs, the Office for Protection from Research Risks (OPRR), FDA, or each on a variety of issues. In conjunction with this requirement, the IRB is prepared to receive and act on information received from a variety of sources, such as volunteers, research investigators, or other institutional staff. For reporting purposes, the IRB will follow the procedures described below:

A. Any serious or continuing noncompliance by research investigators with the requirements of the IRB — This information shall be reported promptly to Academic Affairs and the appropriate federal office.

B. Injuries to volunteers — Information received by the IRB concerning injuries to volunteers shall be reported promptly to Academic Affairs and the appropriate federal office.

C. Unanticipated problems — Information received by the IRB concerning unanticipated problems involving risks to volunteers or others shall be reported promptly to Academic Affairs and to the appropriate federal office.

D. Suspension or termination of IRB approval — The IRB suspending or terminating approval of research projects shall include a statement of the reasons for the IRB's action and shall report the action promptly to the research investigator, Academic Affairs and the appropriate federal office.

IRB Meetings

The Detroit Mercy IRB attempts to meet on a regular basis six times a year. A majority of the membership of the IRB constitutes a quorum. This quorum must include at least one member whose primary concerns are in nonscientific areas. A quorum is required in order to convene a meeting for the review of project protocols. When the IRB reviews an investigational new drug (IND) study, the FDA expects at least one physician member to be present at the meeting. This regulation also requires a majority vote of those present. Meeting dates may be confirmed, and placement on the IRB agenda may be accomplished, by contacting the chair. A project proposal must be received by the chair three weeks prior to a scheduled meeting.

Volunteer Recruitment Advertisements

Advertisements used to recruit volunteers should be prepared according to principles specified in Advertising for Study Volunteers. Such advertising copy must be submitted to the IRB for review and approval with the materials identified under what needs to be submitted for the IRB review on the IRB Home Page.

Continuing Review

Approved projects require annual review and approval by the IRB. The need for continuing review is determined by the IRB appropriate to the degree of risk, but not less than once per year. The Review Report must be completed and returned to the chair at least one month prior to the IRB approval expiration date. When adverse events occur or changes are desired, a revised project protocol along with updated forms should be submitted to the chair with changes highlighted. While the IRB will notify the investigator when a study is due for renewal, the investigator is still responsible for ensuring that the study is not conducted after IRB approval has expired. The investigator need not attend the meeting as long as there were no unexpected side effects or changes to the consent form or project protocol. Only those projects which received an initial approval via expedited review may be granted a continuation via expedited review. The IRB will notify the investigator in writing of its decision.

Revisions to Previously Approved Projects

If it becomes necessary to revise an approved project protocol or consent form, it is the responsibility of the investigator to submit, through their department heads, such a request for an amendment to the IRB chair in writing. The written request must include the following information:

Name and department of the investigator.

Title of the research project.

Project protocol number.

Reasons which make the amendment necessary.

A revised consent form with changes highlighted, if applicable.

Changes in research during the period for which IRB approval has already been given, may not be initiated by research investigators without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the volunteers. Research investigators, department heads, and thesis/dissertation or faculty advisors are responsible for complying with all IRB decisions, conditions and requirements.

Projects Which May Qualify for an Exemption or an Expedited Review

The exemption or expedited approval of research on volunteers is a privilege, not an entitlement. An investigator who thinks a project qualifies for exemption (See Research Activities Which May Be Exempt From Review) or expedited review (See Research Activities Which May Be Reviewed Through Expedited Procedures) and approval should submit a memo of justification with the project, citing the appropriate clause from the Federal Regulations referenced in these documents. Under no circumstances may investigators exempt themselves, nor may investigators be exempted by department heads or thesis/dissertation advisors; all exemptions require concurrence by the IRB. Neither can exemptions nor expedited approvals be requested orally, in person or by telephone.

Investigators who believe their project qualifies for either exemption or expedited review must also submit one copy eachof the Detroit Mercy IRB Project Information Summary, an informed consent form, and the research project. These materials should be submitted to the chair. They will be reviewed by the chair, who will determine if they are qualified for either exemption or expedited review. During such review, the chair will determine whether or not the use of the consent form will be required. If the project is of such a nature that a determination cannot be made by the chair alone, other members of the IRB may be asked to assist with the review. Investigators will be notified in most cases within 10 working days as to the disposition of their requests. The IRB will be notified in writing by the chair at each regularly scheduled meeting of all projects approved via expedited review in the interim between such meetings.

Informed Consent Regulations

The Department of Health and Human Services (HHS) requires that research investigators provide the following information to each participant:

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
2. A description of any reasonably foreseeable risks or discomforts to the subject.
3. A description of any benefits to the subject or to others which may reasonably be expected from the research.
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or whether further information may be obtained.
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

When required by the IRB, the research investigator shall provide one or more of the following additional elements of information to each participant:

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
2. Anticipated circumstances under which the subject's participation may be terminated by the research investigator without regard to the subject's consent.
3. Any additional costs to the subject that may result from participation in the research.
4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
6. The approximate number of subjects involved in the study.

A statement describing the extent of confidentiality of records. On drug studies, this should include a statement that the records may be reviewed by the FDA.

A statement that informs the volunteer that he or she will receive a signed copy of the consent form.

Informed Consent Options

In most cases, the IRB requires the informed consent be documented in writing. Language of the form should be aimed no higher than the eighth grade reading level. Under certain circumstances, alteration or waiver of the standard written informed consent is granted by the IRB. Options that may be acceptable include oral consent (for telephone surveys), a short form consent for participants who do not speak English, and an information sheet in lieu of written consent. Federal regulations govern the use of these options. Investigators may consult with the IRB for guidance.